The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved garadacimab (brand name Andembry) for patients aged 12 years and older with hereditary angioedema (HAE) to ...

This follows the MHRA’s ambition to remain a globally ... The IRP can be used for most new marketing authorisation applications, including generic, hybrid, and biosimilar applications, as ...

For information, the company have advised that they are no longer pursuing a Marketing Authorisation Application from the Medicines and Healthcare products Regulatory Agency (MHRA) for this indication ...

The MHRA has released statistics on its pharmacovigilance inspections performed between April 2014 and March 2015. During this period, it conducted 46 inspections of marketing authorisation ...

MeiraGTx's financials show $125 million in cash, but additional funding will be needed within the next 12 months. Click for ...

LEO Pharma will be gaining the rights to commercialise Junshi Biosciences’ toripalimab in Europe under a new distribution and ...

Adjusted diluted EPS, which is a non-GAAP financial measure that excludes items described below, UK MHRA marketing authorization follows recent European Commission Marketing Authorization for ...

Three players in the biosimilar space have already sparked hope for the new year, with each having big business or regulatory ...

GSK (GSK) stock in focus as its experimental drug depemokimab undergoes EU review for asthma and nasal polyps. Read more here ...

GSK (GSK) announced that the European Medicines Agency, EMA, has accepted for review the Marketing Authorisation Application, MAA, for the use ...

Moderna and Novo Nordisk are once again in the bad books of the U.K.’s drug marketing watchdog. | Moderna and Novo Nordisk ...